Specialist QC system/equipment

ph3Overview /h3 pSummary /p pThe QC Equipment and System Specialist plays a key role in supporting and maintaining Quality Control (QC) equipment and systems, with an emphasis on Laboratory Information Management Systems (LIMS) and associated analytical software tools, QC equipment selection, qualification and lifecycle management and computerized systems methods. /p pThe position involves cross-functional collaboration with QC, QA, and IT, and global stakeholders to ensure data integrity, system compliance, and operational efficiency. The role requires deep expertise in QC equipment and associated softwares, LIMS QC processes implementation (preferably LabWare), strong project coordination skills, and the ability to translate QC user needs into effective technical solutions. The QC System Specialist drives system validation, process improvements, report customization, and contributes to new equipment implementation and data lifecycle management. /p h3Key Responsibilities /h3 ul liLead QC equipment selection via URS creation, support equipment qualification and lifecycle management and interface with internal stakeholders (Quality operations, Engineering, Calibration/Qualification). /li liCoordinate with LIMS administrators and global teams to support system enhancements, issue resolution, and UAT reviews. /li liAct as a key contributor in LIMS-related projects including new equipment and software implementations (Empower, SoftmaxPro, SoloVPE, …), from requirement gathering to technical execution and validation. /li liLead or support validation of computerized systems including URS creation, protocol development, execution, and compliance documentation. /li liCreate, manage and maintain computerized systems methods and protocols. /li liActively lead and participate to QC digital/computerized projects and improvement (e.g. Custom Fields validation, Excel file validation) /li liInterface with digital reporting systems (e.g., Power BI, MES/Skyland) to support integration and data visualization needs. /li liManage and maintain reports and templates within LIMS and related software to meet QC operational needs. /li liSupport deviation investigations, change control (CC), and GxP documentation updates related to QC computerized systems. /li liDrive implementation of streamlined new processes within LIMS according to project timelines. /li liEnsure compliance of LIMS UAT processes and configuration changes. /li liLiaise with stakeholders (QA, QC, IT, vendors) to ensure cross-functional alignment on system functionalities and regulatory compliance. /li liAct as the QC system SME during internal and external audits, providing technical documentation and explanations. /li liProactively identify system improvement opportunities and lead corrective/preventive actions related to QC systems. /li /ul h3Education and Experience /h3 ul liBachelor's or Master's degree in life sciences, IT, bioinformatics, or engineering. /li li5-10 years of experience in the biotechnology or pharmaceutical industry in a GMP-regulated environment. /li liProven hands-on experience with LIMS (preferably LabWare) and analytical software (Empower, SoftmaxPro, SoloVPE, etc.). /li liExperience in system validation, project coordination, and regulatory compliance. /li /ul h3Knowledge, Skills, Abilities /h3 ul liStrong expertise in LIMS administration, technical configuration, and validation. /li liStrong expertise in QC computerized systems (e.g., Empower, SoftMaxPro) /li liSolid understanding of GMP guidelines, data integrity, and computerized system validation (CSV). /li liExcellent project coordination skills, especially in cross-functional environments (QC, QA, IT). /li liStrong communication skills in English (written and spoken); ability to collaborate with US-based teams. /li liTechnical problem-solving mindset, capable of translating user requirements into structured technical solutions. /li liProactive, self-driven, and comfortable taking ownership of complex topics. /li liStrong leadership capabilities to drive system-related initiatives, report on progress, and influence stakeholders. /li liAbility to manage multiple priorities while maintaining attention to detail and compliance. /li /ul pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p /p #J-18808-Ljbffr